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07/22/2014

Update on Hospice & Medicare Part D: Revised Guidance thanks to Hospice Advocacy

At Outcome Resources, “Helping Hospices Succeed” is more than just a tagline, it is our mission and our primary focus every day. As we consult with our hospice partners, patient care is our number one priority. With patient care impacted by Medicare Part D guidance issued by CMS, Outcome Resources has provided our hospice partners with education via live webinars and consultations and supporting documentation via our Medication Reviews, and then we worked with NHPCO and the Hospice Action Network to change the rules.

As the sole hospice pharmacy partner to sponsor the Hospice Action Network Advocacy Intensive last month in Washington D.C., we are proud that our commitment to hospice advocacy has helped to result in revised guidance being issued by CMS. In addition to our team traveling to D.C. to meet with Congress, we also provided scholarships to 22 attendees of this year’s Advocacy Intensive from around the nation, to ensure that as many legislators as possible were reached with this very important message regarding hospice and Medicare Part D. Thanks to all of us in the hospice community, including those of you who participated by calling in to speak with your congressmen and senators, our voices have been heard!

Revised guidance has been issued as of July 18th. This revised guidance does provide substantial relief of the burden for hospice providers since prior authorizations will only be required on the four categories identified as typically used in hospice: analgesics, antinauseants (antiemetics), laxatives, and antianxiety drugs (anxiolytics). Other drugs will not have to go through the PA process. You may read the full CMS Memo for more information.
We urge you to make special note that the guidance emphasizes the need for hospices to include a comprehensive written drug profile as part of the hospice plan of care. While this Medication Review meets the need for Conditions of Participation, it now also may be provided to a Part D sponsor during the PA process. Outcome Resources has provided the most comprehensive, best in industry Medication Reviews well before these requirements were put in place. We invite you to compare our Medication Reviews to what you are currently receiving. While these are the #4 reason for being cited in survey, no Outcome Resources partner has ever been cited for Medication Reviews.

To learn more about hospice advocacy and the hospice regulatory environment, join us at the Annual Pathways to Success Hospice Conference this November in Berkeley, California. Jon Keyserling of NHPCO will address Hospice Advocacy and Policy in 2015, and Susan Balfour will discuss Hospice and the Letter People, and how to keep up with regulatory changes. Drs. Glen Komatsu and Stephen Leedy will keynote the two day Conference, and you may earn up to ten contact hours of continuing education. View the Full Agenda and Register Today!

Photo: Outcome Resources CEO Dr. Martin McDonough Addresses Attendees at the Hospice Action Network Advocacy Intensive, June 2014
 




06/30/2014

Hospice Item Set (HIS) - CMS Quality Data Collection Starts on July 1st 2014

Esther Liu, PharmD, MSIA, CGP

HIS is a patient-level data collection tool developed as part of the Hospice Quality Reporting Program (HQRP), which can be used to collect data to calculate 6 National Quality Forum-endorsed (NQF) Measures and 1 modified NQF Measure. See below for a list of measures required:

1. NQF #1617 Patients Treated with an Opioid who are Given a Bowel Regimen
2. NQF #1634 Pain Screening
3. NQF #1637 Pain Assessment
4. NQF #1638 Dyspnea Treatment
5. NQF #1639 Dyspnea Screening
6. NQF #1641 Treatment Preferences
7. Modified NQF #1647 Beliefs/Values Addressed (if desired by the patient)

HIS is implemented as part of the FY 2014 Hospice Wage Index Final Rule issued last year in July 2013. To refresh your mind regarding HIS submission, you may visit the CMS website to view the training materials. CMS requires ALL Medicare-certified hospices to submit HIS data on ALL patients. Please be aware of the completion and submission deadlines. Data collection of HIS for each admission must be completed within 14 days and submitted to CMS within 30 days after admission. Data collection for HIS for discharged patients must be completed within 7 days and submitted to CMS within 30 days after discharge.  If the hospice failed to be compliant in reporting patient admission/discharge data, this would impact its payment rate in fiscal year of 2016.

As a Pharmacy Benefit Manager, we help our hospice partners to collect data to fulfil HIS requirements related to medications. To learn about the different reporting tools we offer to our partners, please contact the clinical department at clinical AT outcomeresources DOT com or Submit Your Information and we will contact you directly.




06/27/2014

Hospice Medication Alert: New PPI Available OTC - Nexium 24HR

Jennifer Chen, PharmD

On March 28th, FDA approved the over-the-counter Nexium 24HR (esomeprazole magnesium) 20mg delayed-release capsules. Nexium is part of a class of drugs called proton pump inhibitors (PPIs), which is commonly used for gastroesophageal reflux disease (GERD), erosive esophagitis and prevention of NSAID-induced gastric ulcers. This purple pill, previously available by prescription only, is now available over-the-counter providing patients who suffer from frequent heartburn an easier access.

However, Nexium 40mg delayed-release capsules still remains available by prescription only as well as other formulations of Nexium including Nexium I.V. and Nexium oral suspension. For patients with difficulty swallowing, the Nexium 24HR capsule can be opened and mixed in applesauce.

The status change to OTC does not take away its potential harms. Its side effects include headache, diarrhea, increased infection and bone fractures. In general, short-term use of PPI is safe. The approved OTC labeling is a 14-day treatment and may be repeated every 4 months.

As mentioned in a previous article, Nexium was the number 2 drug in “Top 100 Drugs by Sales” over the past year. The cost for Nexium 24HR is significantly lower than the prescription version (about 1/10th the cost of prescription Nexium). The OTC availability of Nexium 24HR provides another cost-effective alternative for hospice patients. Other PPIs available in OTC formulations are Prevacid (lansoprazole) and Prilosec (omeprazole).




06/26/2014

Medication Errors: The Problem of Look-Alike, Sound-Alike Drug Names

Jim Joyner, PharmD, CGP

One of the most common sources of medication errors is the problem of “look-alike” and/or “sound alike” drug names.  The risk for serious errors can arise when medication orders or prescriptions are not written clearly and the reader misinterprets the intended drug for a different drug with a very similar spelling.  Another variation on this error theme is when a drug name is transmitted verbally (either directly or more likely, over the phone) which sounds very similar to a different drug.  The listener may hear a different drug name than that which was intended.  There are very many drugs that fit into these categories of look-alike and sound alike drugs, providing the clinician with a great many opportunities for misinterpretation. This table provides just a few examples. (You may wish to share this with your staff.)

There are a number of ways to reduce the risk for this type of error through increased clinician awareness of the problem, coupled with a variety of safe practices.  Here are a few safe practices that are worth consideration:
  
• Put the drug name that you heard or read into the context of the overall medication order; does the strength, frequency for use, and reason for use make sense for the drug name? 

• Know what the medication is intended to be used for.  Is the drug name that you heard indicated or commonly used for managing that type of condition or symptom?

• If the person transmitting the order verbally is not clear or has an accent that you are not familiar with, ask them to spell it out. 

• When initiating an order in writing or verbally, consider using both the brand name AND generic name.

• When initiating an order, consider including the “reason for use” in the medication order.    Such as “for depression” or “for arthritis”.

• When selecting drug line items from a computer data-base, keep in mind that look-alike drug names may appear consecutively in the list, making the incorrect selection a high probability.  Double – check all selections for accuracy against the intended drug name.  

• Some computerized drug data bases can be configured to change the appearance of look-alike drug names to draw attention to their dissimilarities.  This is done with the use of “tall man” (mixed case) lettering. 

• Develop a working knowledge of actual look-alike and sound-alike drug names.  The Institute for Safe Medication Practices (ISMP) has a very extensive list of drug name pairs that have been reported as error related events of this type.  The ISMP list is updated every few months.  Refer to http://ismp.org for more information on this topic and other medication error issues.  

Photo Credit

 

More information:
http://marketing.outcomeresources.com/acton/attachment/4185/f-018a/1/-/-/-/-/Commonly%20Used%20Look%20Alike%20Sound%20Alike%20Medications.pdf


06/23/2014

Hospice Legislative Update: The 2014 HAN Advocacy Intensive

Outcome Resources considered it an honor to recently sponsor the 2014 Hospice Action Network Advocacy Intensive in Washington, D.C. Together with over 200 hospice professionals we had the opportunity to share our hospice stories with nearly all of the nation’s Senators and State Representatives. In addition, this year, twenty advocates whose hospice programs would otherwise be unable to afford it were able to attend the Hospice Action Network’s Advocacy Intensive thanks to Outcome Resources scholarships. It is vital to bring these stories to Congress and have our voices heard on Capitol Hill.

The support of our elected officials is crucial to protect and preserve the hospice Medicare Benefit and to support legislation that positively affects those patients and families facing end of life. We are grateful to the Hospice Action Network for providing all of us involved in hospice the forum and opportunity to speak with a unified message in support of our daily efforts. During the meetings on the Hill with Representatives, Senators, and Legislative Assistants, this year advocates focused on requesting support with the issue of Hospice and Medicare Part D. (Learn more in our previous blog post about the issue.) As you may be aware, CMS issued guidance to the Part D provider and hospice communities introducing a “prior authorization” process for how the two groups should determine who pays for which drugs once a patient elects hospice. Since there is no uniform process in place, hospices are dealing with multiple Part D prior authorization processes and paperwork that in many cases requires the addition of staff, and patients are trapped in the middle of this confusing process – sometimes even deciding to disenroll from hospice or being left without medications.

To learn more about these issues or how you can help, please visit Hospice Action Network. You can also participate by calling your members of Congress. Outcome Resources has been involved as hospice advocates for many years and will continue to support these efforts at every opportunity. We are honored to have Jonathan Keyserling, Senior Vice President, Office of Health Policy and Counsel at the National Hospice and Palliative Care Organization presenting a session on Hospice Advocacy at the Outcome Resources Pathways to Success Conference by the Bay this November. To learn more about the Conference, visit the Conference Website or Download the Information Sheet.

View our photos of the HAN Advocacy Intensive on Facebook at http://on.fb.me/1m4GXvz.




06/05/2014

Update on High Cost Drugs In Hospice

Dr. Jim Joyner, PharmD, CGP

A recent article appeared in the Medscape News on-line site which presented the “Top 100 Drugs by Sales” over the past year. All of these drugs were brand-name products. The drugs made the list through a combination of two factors; popularity among prescribers and having a high cost. Thirteen of the drugs on this list are drugs that we see routinely prescribed for hospice patients to varying degrees. In light of limited hospice reimbursement rates and extremely tight budgets, it is appropriate for hospice organizations to evaluate current usage of these highly prescribed, high cost drugs. The remainder of this article will identify these drugs and discuss possible cost-effective alternatives.  

First, the 13 drugs are presented here with corresponding reported $ sales figures for the past year  (April 2013 – March 2014). Drugs are ranked from highest sales dollars to lowest:

Drug   Sales in billions
Abilify              6.9
Nexium           6.3
Advair              5.1
Spiriva             3.1

                                                                                         Lyrica               2.6
                                                                                         Oxycontin        2.5
                                                                                         Celebrex         2.3
                                                                                         Namenda       1.9
                                                                                         Symbicort       1.7
                                                                                         Seroquel XR  1.3
                                                                                         Dexilant           1.0
                                                                                         Lunesta           0.9
                                                                                         Combivent      0.8

Abilify was the number one drug on the Top 100 list for highest sales overall.  This is the most expensive antipsychotic drug available.  Terminal delirium and related psychoses or agitation experienced by hospice patients may often respond very well to much less expensive antipsychotic drugs such as Haloperidol or Risperidone (about  1/30th  and 1/5th  the cost of Abilify, respectively).    

There were 2 PPI’s (proton-pump inhibitors) on the list;  Nexium took the number 2 spot and Dexilant was number 56 on the Top 100.  Effective management of gastric distress in hospice patients may often be achieved with the oldest generic PPI, Omeprazole.  Omeprazole OTC is about 1/15th  the cost of these two brand name PPI’s.   

Advair and Symbicort are both long-acting beta agonist (LABA) / steroid combination inhaler drugs which are dosed twice daily.  Both are expensive. There are no low cost LABA/Steroid combination products currently available. One option for low-cost alternative therapy in hospice is to use the short-acting beta-agonist, Albuterol (four times daily), plus an oral steroid such as Prednisone 5 - 10mg daily.  Long term use of oral steroids is associated with higher incidence of side effects, however, in the hospice setting such long-term use may not be a relevant concern. The Albuterol plus Prednisone option would be about 1/10th the cost of the Advair or Symbicort.    

Two other inhaled respiratory medications on the list were Spiriva and Combivent metered dose inhalers (MDI’S).   Spiriva is an anticholinergic-type bronchodilator (tiotropium) and Combivent is the combination of the anticholinergic bronchodilator, Ipratropium, and the beta-agonist bronchodilator, Albuterol. While there is no low cost alternative to these products in metered-dose-inhaler (MDI) dosage form, there is a good low cost alternative in the nebulizer solution dosage-form of the albuterol-ipratropium combination product, also known as Duoneb (about ½ the cost of Spiriva or Combivent therapy).  

Lyrica is used for both seizure management and control of neuropathic pain in hospice patients.  A reasonable cost-effective alternative is Gabapentin which is about 1/4th  the cost of Lyrica in equivalent doses.  

Oxycontin is one of the most expensive long-acting opioids available.  Methadone is a very effective alternative at about 1/30th the cost for an equivalent dose. Methadone also has the advantage of being available in a liquid dosage-form for those patients who have difficulty swallowing whole tablets. Oxycontin tablets should not be crushed.  Morphine Extended Release tablets may also be a reasonable alternative at about 1/3 the cost of Oxycontin.  Like Oxycontin, the morphine extended release tablets should not be crushed.

Celebrex is a Cox-2 selective non-steroidal anti-inflammatory (NSAID). This is the only cox- 2 selective NSAID currently available and therefore has a distinct advantage in patients where there is significant concern or history of NSAID induced gastric side effects.   Alternatives for patients that are not in that category would in include Naproxen, Ibuprofen, and Meloxicam. These options are all about 1/10th the cost of Celebrex in equivalent doses. 

Namenda may be effective for management of cognitive symptoms encountered in moderate to severe dementia.   There is no evidence that this drug has any significant benefits in “end-stage” dementia, classified as Level 7a or greater using the FAST rating scale. By definition, a patient with a hospice diagnosis of dementia would be at Level 7a or greater, so continued therapy with Namenda would not be recommended once the patient is admitted to hospice with this diagnosis.  

Seroquel XR is the extended-release (once daily) version of the antipsychotic drug, quetiapine immediate release (twice daily). Quetiapine immediate release is available as a generic and is less expensive than the XR form with only minimal adjustment for dosage compliance (one dose per day vs two).  An even more cost-effective option is Haloperidol which is about 1/12th the cost of generic quetiapine in equivalent doses. 

Lunesta is a sedative-hypnotic which is used for management of insomnia in hospice patients.  Lunesta has recently gone generic (Eszopiclone), however, even that version is still pricey.  There are a couple of cost-effective alternatives: Temazepam (a benzodiazepine sedative hypnotic) and Trazodone (a sedating antidepressant).  Trazodone and Temazepam have been used extensively in hospice for managing insomnia with good results.  Both of these alternatives are about 1/15th the cost of Eszopiclone.  

Conclusion:  The cost-effective alternatives discussed in this article may not be appropriate for all hospice patients, and consideration of the individual patient’s drug history and comorbid conditions need to be factored into any decision to change medications.  On the other hand, each of the alternative medications suggested here have been widely used in hospice and palliative care settings for long periods of time with positive results. While not appropriate for all patients, these alternative medications should be considered as possible first-line therapies for the majority of hospice patients.  

For additional information on equivalent doses and corresponding costs, there are some helpful Hospice Medication Charts on the Outcome Resources website that provide detail about inhaled respiratory medications, PPI’s, and benzodiazepines.  You can find these under Clinical Resources in the member’s section. Outcome Resources hospice clients can also contact our clinical pharmacist staff for specific recommendations as needed.  




05/22/2014

New Wound Care Management Course added to Outcome Resources Education Portal

Dr. Jim Joyner, PharmD, CGP

I am pleased to announce that the online education section of OutcomeResources.com has been updated with a new course:  "Wound Care for Hospice Patients."  This is a very interesting and informative course that addresses the complex issues of wound management in hospice patients.  Our presenter is wound care specialist Kristen Lyn Brodrick, RN, BSN, CHPN, CWCN. The unique challenges of wound care management in hospice patients is presented through the eyes of a wound care specialist and certified hospice & palliative nurse. A description of the wound healing process sets the stage for this informative presentation, followed by a detailed discussion of the types of wounds encountered in the hospice patient.  Information about the staging of various wounds is explored. The presentation concludes with specific guidance about the role and application of various treatment modalities including a variety of wound care dressings and debridement. This program is approved by the California Board of Registered Nurses (BRN) for 1 contact hour of continuing education*. Outcome Resources partners may log on to the Members Only section of OutcomeResources.com to register for this course.

There are also two companion articles which appeared in the Outcome Resources newsletter, The Clinician, which may be of interest to those exploring this topic:

“Wound Care and the Hospice Patient:  The Perspective from a Wound Care Specialist”
Kisten Lynn Brodrick, RN, BSN, CHPN, CWCN
January 2014  Volume 9, Issue: 1

“A Discussion About Wound Care Products and Factors That Impeded Healing”
Jim Joyner, PharmD, CGP
October 2013   Volume 8,  Issue: 4  

_______________________________________________________________________________________________

Registration is now open for our Annual Conference, Pathways to Success: Conference by the Bay, which will be held November 12th-13th in Berkeley, California. An expert panel of speakers will be addressing hot topics in both clinical and administrative tracks, and you will have the opportunity to earn up to 10 contact hours of continuing education.* Learn more about this exciting hospice and palliative care conference at www.outcomeresources.com/hospice-conference.

(*Provider approved by the California Board of Registered Nursing, Provider Number 14850)




04/25/2014

Citalopram for Agitation Associated with Alzheimer’s Disease: Results of the CitAD Trial

Dr. Julia Harder, PharmD, CGP

Agitation is a common symptom experienced by hospice patients with Alzheimer’s Disease (AD), and is associated with significant distress on the part of patients, caregivers, and healthcare professionals. Current treatment options include non-pharmacologic management strategies, which are first-line but frequently insufficient, and pharmacologic strategies. The antipsychotics (such as haloperidol, risperidone and quetiapine) are the cornerstone of pharmacologic management of agitation in AD, but these medications are associated with increased mortality in elderly patients with dementia. In recent years, the use of antipsychotics for this indication has been widely discouraged by the FDA, and their use has been under scrutiny and investigation. New and better therapies for agitation associated with AD are direly needed, especially in hospice.

The Citalopram for Agitation in Alzheimer Disease (CitAD) Study was recently published in the Journal of the American Medical Association. This randomized, placebo-controlled, double-blind, parallel group trial of 186 patients with Alzheimer’s Disease and persistent moderate to severe agitation found that citalopram (at a dose of 30 mg per day) significantly reduced agitation and caregiver distress. However, this benefit was tempered by an increased risk of cardiovascular adverse effects, specifically prolongation of the cardiac QT interval.

Study participants were randomized to receive psychosocial intervention (educational materials, counseling, 24-hour crisis management) plus either citalopram or placebo for 9 weeks. Citalopram dosage began at 10 mg per day, with titration to 30 mg per day over 3 weeks based on response and tolerability. The majority of patients ended up taking the full 30 mg target dose. After the start of the study, the FDA issued its advisory that citalopram should not be prescribed at doses over 20 mg in patients older than 60 years because it causes dose-dependent QT prolongation (see our previous blog post on this topic). This advisory led the study investigators to include strict electrocardiogram (ECG) monitoring, and to exclude from the study any patients who showed QT prolongation on ECG.

At week 9 of the study, the analysis found a significant improvement in the treatment group compared with the placebo group on the 18-point Neurobehavioral Rating Scale-Agitation (NBRS-A), which assesses agitation, hostility/uncooperativeness, and disinhibition, with higher scores indicating more severe symptoms. The mean estimated treatment effect on the NBRS-A (the difference in scores at week 9, controlling for baseline score and MMSE score) was –0.93 (95% confidence interval, –1.80 to –0.06; P = .04).

In addition, 40% of the patients receiving citalopram had moderate or marked improvement from baseline severity on the 7-point modified Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change score, which assesses items specific to agitation in AD. This compared to 26% of the patients taking placebo.

According to the study’s lead investigator, Dr. Anton Porsteinsson, this effect of citalopram on agitation is about the same as that of atypical antipsychotic drugs, such as quetiapine and risperidone.

The downside is that patients in the treatment group did show QT prolongation (18.1 ms; 95% CI, 6.1-30.1; P = .01) compared to the placebo group. "Our findings support the FDA," said Dr. Porsteinsson. "If nonpharmacological intervention is not beneficial, judicious use of citalopram appears to have a role in managing agitation in patients with Alzheimer's disease, but generally, the dose should not surpass 20 mg per day."

The study didn't include enough patients taking 20 mg of citalopram to determine whether this dose affected the QT interval or whether it also led to reduced agitation. So, next on the research agenda is applying for funding to look at 20 mg as the target dose, said Dr. Porsteinsson. "The aim is to treat people with clinically meaningful agitation and see if that dose has similar agitation efficacy and if it reduces caregiver burden to the same degree, but without the QTc findings.”

Reference
Porsteinsson AP, Drye LT, Pollock BG, et al. Effect of Citalopram on Agitation in Alzheimer Disease: The CitAD Randomized Clinical Trial. JAMA 2014;311:682-691.

Photo Credit




04/04/2014

FDA Approves Evzio® (Naloxone Hand-Held Auto-Injector) For Opioid Overdose

Dr. Julia Harder, PharmD, CGP

Drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. Opioid overdose, in particular, has been steadily rising over the past decade, and has been the subject of intense FDA focus and regulation.

As we know, naloxone is an opioid receptor antagonist that rapidly reverses the effects of opioid overdose and is the standard of care. However, existing naloxone drugs require intravenous administration and are most commonly used by trained medical personnel in emergency departments and ambulances.

Yesterday, the FDA approved Evzio (naloxone HCl injection, manufactured by Kaleo, Inc.) for the emergency treatment of known or suspected opioid overdose. Evzio is a hand-held auto-injector that rapidly delivers a single 0.4 mg dose of naloxone as an intramuscular or subcutaneous injection into the thigh. The auto-injector, which is about the size of a cell phone, can be carried in a pocket or stored in a medicine cabinet, to be used by family members or caregivers in the case of suspected opioid overdose, as manifested by respiratory and/or central nervous system depression (e.g., extreme sedation or loss of consciousness). Evzio is approved for use in adult and pediatric patient (even infants).

Evzio is not intended to be a substitute for immediate medical care. The duration of action of most opioids exceeds that of naloxone, meaning that respiratory and/or CNS depression may recur after an initial improvement in symptoms. Therefore, the administrator should always seek immediate medical attention after giving the first dose of Evzio, and should repeat doses of Evzio every 2-3 minutes, depending on the patient’s response, while waiting for emergency medical assistance.

Evzio was reviewed under the FDA's priority review program and was also granted a fast track designation. Evzio is expected to be available this summer as a carton containing 2 prefilled auto-injectors and a single Trainer injector.




03/25/2014

Vortioxetine (Brintellix™): A New Multimodal Antidepressant and its Place in Hospice Care

Dr. Julia Harder, PharmD, CGP

On September 30, 2013, a new antidepressant, vortioxetine (Brintellix™ -- Lundbeck and Takeda), was approved by the FDA. Vortioxetine is considered a “multimodal antidepressant”, which puts it in a class of its own. This blog post will summarize important points about the clinical use of vortioxetine, especially in the hospice population, in whom depression is very common.

Mechanism of Action

Vortioxetine is thought to work through a combination of both serotonin reuptake inhibition and serotonin receptor activity, including agonism at the 5-HT1A receptor and antagonism at the 5-HT3 receptor. As a result of this multimodal and partially novel mechanism of action, vortioxetine may hold promise for patients who have failed to respond to first-line treatment options. Vortioxetine may also have beneficial effects on cognition, which is currently being investigated further.

Efficacy Data

Data from both short- and long-term randomized controlled trials (RCTs) have demonstrated vortioxetine’s efficacy both in the treatment of major depression and in preventing relapse. International data have shown significant efficacy of vortioxetine in a dose range from 5 to 20 mg/day but most consistently at doses of 10-20 mg/day. Two low-dose studies, (2.5 mg/day and 5 mg/day of vortioxetine) did not show superiority over placebo. Furthermore, antidepressant efficacy has been demonstrated specifically in an elderly population (mean age, 70.6 years), which is unique among the antidepressants. An RCT of more than 450 elderly adults with major depressive disorder from 7 countries showed that those treated with vortioxetine showed significantly greater improvement on several depression rating scales and cognitive tests compared with those who received placebo.

Vortioxetine has also shown efficacy in patients who have already failed a first-line antidepressant. The REVIVE study compared the efficacy of vortioxetine with the most recently approved novel antidepressant in Europe, agomelatine, in a well-powered, head-to-head trial. Of note, the patients were non- or partial responders with a history of at least 6 weeks of treatment with an SSRI or SNRI who were then abruptly switched to 12 weeks of randomized treatment with either vortioxetine (10-20 mg/day) or agomelatine. In this "out of class" switch strategy for patients with insufficient response to first-line antidepressants, vortioxetine led to significantly greater improvement in depression scores at 8 weeks compared with agomelatine, with similar effects at week 12.

Finally, on the basis of its mechanism of action, vortioxetine is being studied for potentially beneficial effects on cognition. Initial data on the potentially procognitive effects of vortioxetine, independent of the drug's effects on symptoms of depression, have been generated in elderly patients with major depressive disorder. Other studies with cognition as a primary outcome are ongoing.

Safety Data

The most common adverse effects of vortioxetine across multiple studies were nausea, diarrhea, dry mouth, sweating, and headache – standard antidepressant side effects. Of these, nausea seems to be the most common. The potential benefits of vortioxetine include low rates of sedation/somnolence and insomnia, low weight gain in both short- and long-term studies, and less sexual side effects than the SSRIs.

Like other antidepressant medications, vortioxetine has an FDA boxed warning and a medication guide alerting patients and healthcare professionals that antidepressants can increase the risk for suicidal thought and behavior in children, adolescents, and young adults aged 18 to 24 years during initial treatment.

Dose

The recommended starting dose is 10 mg orally once daily, taken at any time and without regard to food intake. The dose should then be increased to 20 mg/day, as tolerated, with consideration being given to lowering the dose to 5 mg/day for patients who do not tolerate higher doses. Vortioxetine is currently available as brand-name only (Brintellix™), in 5 mg, 10 mg, and 20 mg tablets.

Pharmacokinetics

Vortioxetine has a favorable pharmacokinetic profile. It is metabolized by several different liver enzymes (rather than predominantly just one or two), which means that is does not have many drug interactions beyond the normal ones we are familiar with (tramadol, linezolid, methylene blue, monoamine oxidase inhibitors, triptans) that interact with all serotonergic antidepressants. Vortioxetine also has a long half-life of about 60 hours, which means that rebound or withdrawal will be unlikely if patients miss doses or have to abruptly discontinue the medication due to the loss of swallowing ability.

Cost

Currently, Brintellix™ is one of, if not the, most expensive antidepressants on the market, with an average wholesale price of $8.72 per tablet (same price for all strengths). By comparison, levomilnacipran (Fetzima™, another new antidepressant approved in 2013 that is still brand only) is $8.10 per tablet, escitalopram is about $4.50 per tablet, and citalopram is about $2.50 per tablet.

Place in Hospice Therapy

Vortioxetine has many positive characteristics, including a multimodal mechanism of action, demonstrated efficacy in the elderly, favorable pharmacokinetics, and a relatively short list of side effects. However, because of lack of clinical experience and very high cost, vortioxetine should not be used as a first-line agent for the treatment of depression in hospice. As a result of the diverse and partially novel mechanism of action of vortioxetine, this new multimodal antidepressant may hold promise for a very select group of hospice patients, including:

• Patients who have tried and failed other first-line therapies, including one or more SSRIs
• Patients who have experienced intolerable sedation/somnolence or insomnia with other antidepressants
• Patients with comorbid cognitive deficits

The broader picture of vortioxetine's clinical utility and place in the treatment of patients with depression will need to be established through its clinical use after approval and ongoing and future phase 4 trials. Future studies will hopefully examine whether vortioxetine has more robust efficacy in certain patient subgroups, including treatment-nonresponsive/resistant patients and those with comorbid cognitive problems, as this would be of particular interest to the hospice community.

 




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